This proposal discusses the development Real-time PCR assays using novel prostate cancer markers for the diagnosis/prognosis of prostate cancer. Prostate cancer is a leading cause of deaths among men in the U.S. Good prognosis depends on the early detection of the disease. However, the sensitivity and the specificity of the current available diagnostic markers is insufficient. Using state of the art technology, differential display PCR and cDNA, PCR and electronic subtraction methods, we have identified 8 prostate cancer markers and established their tissue specificity and relationship to tumor stage using Real-time PCR. Five of these novel genes will be evaluated to determine the optimal combination for use in Real-time PCR assays to detect micrometastases in blood using epithelial cell immunocapture methods. Antibodies to proteins derived from the additional three genes will be used to develop a prostate specific immunocapture assay. Real-time PCR with some of the genes using blood samples has already been achieved at Corixa and will be expanded and standardized assays developed. This in combination with collaborations with key investigators in prostate cancer and access to an extensive blood and tissue bank should enable the goals and objectives of this proposal to be achieved. PROPOSED COMMERCIAL APPLICATION: The proposed studies will lead to commercialization of a high throughput RT-PCR assay for diagnosis and/or prognosis of prostate cancer. Such tests would be marketed both in the U.S. and worldwide. The estimated world wide market for such a tests is $200-300 million/year.